Merck Sharp & Dohme LLC vs. Halozyme, Inc. et al.
Explore the PTAB proceeding PGR2025-00009 filed by Merck Sharp & Dohme LLC on 2024-12-27. This includes filing dates, application numbers, tech centers, patent numbers, and current case status.
Proceeding Overview
Proceeding Number
PGR2025-00009
Filing Date
2024-12-27
Accorded Filing Date
2024-12-27
Institution Decision Date
2025-07-11
Last Modified Date
2026-09-21
Proceeding Type
PGR
Termination Date
2026-06-24
Trial Status
Final Written Decision - Appealed
Parties & Counsel
Petitioner
Merck Sharp & Dohme LLC
Represented By
Kushan, Jeffreyet alPatent Owner / Respondent
Halozyme, Inc. et al.
Represented By
Ellison, Eldoraet alTribunal & Venue
Tribunal
Patent Trial and Appeal Board (USPTO)
Technology Center
TC 1600 - Biotechnology & Organic Chemistry
Patent Information
Respondent Application Number
18068327
Respondent Patent Number
12123035
External Links
Respondent Inventor
Ge Wei et al
Respondent Tech Center
TC 1600 - Biotechnology & Organic Chemistry
Address and Attorney/Agent Information
Power of Attorney & Correspondence
Firm
/ Entity Name
Morgan, Lewis & Bockius LLP (PH)
Customer
Number
28977
Address
2222 Market Street, Philadelphia, PA, 19103, UNITED STATES
Attorney / Agent Information
| Reg # | Name | Phone |
|---|---|---|
| 31066 | Gary Williams | 650-843-7501 |
| 37386 | Michael Lyons | 650-843-7507 |
| 39266 | Soyeon Laub | 714-830-0512 |
| 39951 | Douglas Crisman | 650-843-4000 |
| 40506 | Louis Beardell Jr | 215-963-5067 |
| 41040 | Robert Goodell | 202-739-5549 |
| 41796 | Andrew Gray Iv | 650-843-4000 |
| 42223 | Jason White | 312-321-4200 |
| 42813 | Brett Lovejoy | 415-442-1211 |
| 42837 | Jeffry Mann | 415-442-1000 |
| 43378 | Collin Park | 202-739-3000 |
| 44146 | Brent Hawkins | 415-442-1000 |
| 45645 | Dion Bregman | 650-843-4000 |
| 46692 | Ramyar Farid | 202-739-5195 |
| 50801 | Robert Smyth | 202-739-5139 |
| 50862 | Ahren Hsu-Hoffman | 650-843-4000 |
| 50891 | Jeffrey Killian | 202-739-5592 |
| 51793 | Mark Hayman | 617-951-8440 |
| 53615 | Nathan Smith | 949-757-6018 |
| 55202 | Jason Gettleman | 650-843-7593 |
| 55293 | Ari Indik | 215-864-7138 |
| 56890 | Christopher Betti | 312-324-1449 |
| 57765 | Yalei Sun | 650-843-7558 |
| 58729 | Louis-Vu Nguyen | 415-442-1303 |
| 58752 | John Hemmer | 215-963-4816 |
| 59462 | Brad Wilson | 312-324-1103 |
| 59649 | Tae Woong Koo | 650-843-7246 |
| 60472 | M. Hales | 714-830-0514 |
| 60711 | Richard Leung | 215-963-5082 |
| 61841 | Kenneth Cheney | 714-830-0526 |
| 63115 | Michael Ryan | 610-574-1318 |
| 63133 | Stephen Altieri | 617-951-8525 |
| 63328 | Clay Hawes | 7034154864 |
| 64526 | Janice Logan | 202-439-5234 |
| 65210 | Christina Macdougall | 415-442-1277 |
| 65452 | Kelly Plummer | 312-324-1490 |
| 65592 | Liying Sun | 650-843-7215 |
| 66838 | Jianbai Wang | 650-843-7843 |
| 67084 | Maria Doukas | 312-324-1454 |
| 67908 | Yingying Zhou | 415-442-1214 |
| 67961 | Tairan Wang | 202-739-5119 |
| 68345 | Danny Mansour | 714-830-0600 |
| 68487 | Alia Orbin | 610-390-7234 |
| 69096 | Toyomi Ohara | 202-739-3000 |
| 69232 | Rachna Ram | 510-524-1579 |
| 69316 | Byung Cheol Kwak | 617-341-7264 |
| 69333 | Hosang Lee | 202-937-5142 |
| 70067 | Sujohn Das | 713-890-5792 |
| 70236 | Kalpesh Upadhye | 202-739-5157 |
| 70711 | Benjamin Pezzner | 650-843-4000 |
| 70871 | Andrew Antczak | 215-963-5000 |
| 71054 | Yon Sohn | 858-587-1121 |
| 71064 | David Bernstein | 650-843-4000 |
| 71076 | Wan-Shoon Lo | 312-984-5810 |
| 71397 | Alexander Stein | 650-843-7278 |
| 71751 | Moreshwar Vaze | 617-341-7952 |
| 71783 | Nicholas Restauri | 312-324-1000 |
| 72445 | Jianke Kang | 202-739-5183 |
| 73464 | Hang Zheng | 202-585-8307 |
| 73683 | Amanda Williamson | 312-324-1450 |
| 73696 | Chantal Edde | 215-963-5656 |
| 74139 | Ka Lo Yeh | 650-843-7815 |
| 74539 | Sadie Knight | 415-442-1000 |
| 74630 | Victor Ghidu | 215-963-5719 |
| 75253 | Alyssa Pugh | 215-963-5070 |
| 75470 | Sara Sims | 215-963-5630 |
| 75669 | Andrew Dietrick | 570-906-0745 |
| 75688 | Emily Coury | 617-341-7818 |
| 75724 | Alexandra Koseva | 650-843-7211 |
| 75810 | Matthew Walker | 206-274-6374 |
| 75815 | Catherine Chou | 650-843-4000 |
| 76003 | Drew Bennett | 617-341-7833 |
| 76140 | Alexandria Petterson | 650-843-7841 |
| 76203 | Calvin Brien | 202-739-5167 |
| 76671 | Andrew Devkar | 310-255-9070 |
| 77267 | Ai Leen Koh | 650-843-7823 |
| 77446 | Theodore Rand | 650-843-7275 |
| 77698 | Phillip Wolfe | 215-963-5454 |
| 77918 | Alicia Fraind | 215-972-8594 |
| 77996 | Min Woo Park | 202-673-95697 |
| 78072 | Conor Ball | 415-442-1668 |
| 78272 | Sandhal Olds | 765-618-4658 |
| 79029 | Alexander Harrison | 404-815-6046 |
| 79060 | Kannan Narayanan | 408-685-3658 |
| 79300 | Evelyn Chou | 415-442-1609 |
| 79663 | Kathryn Chesnick | 570-878-2384 |
| 79760 | Xiaoqian Li | 650-843-7853 |
| 79839 | Peter Loderup | 714-830-0517 |
| 79856 | Timmy Lee | 650-843-7517 |
| 80363 | Yuqi Li | 215-564-3236 |
| 80469 | Alec Mandell | 650-843-7228 |
| 80622 | Corey Moore | 617-341-7852 |
| 80944 | Hye Hyun Ahn | 202-434-7300 |
| 81040 | Eunjean Je | 202-739-5929 |
| 81210 | Hayley Reed | 215-963-4957 |
| 81433 | Kurosu Altaf | 650-843-7233 |
| 81482 | Pablo Herrera Jr. | 650-843-7512 |
| 81484 | Samantha Kuo | 714-579-5530 |
| 81604 | Xinming Zhang | 415-442-1392 |
| 81935 | Jia Jie Tang | 617-951-8000 |
| 81982 | Corine Martineau | 215-963-5030 |
| 82004 | Isabella Couture | 316-680-1931 |
| 82139 | Xuedong Zhu | 857-333-6217 |
| 82373 | Alyssa Galvin | 202-739-5786 |
Proceeding Documents
200
144
Patent Owner's Notice of Appeal NOTICE
2026-09-21
FILING PARTY: PATENT OWNER
143
Patent Owner's Request for Director Review of Final Written Decision (PUBLIC - REDACTED) OTHER
2026-08-14
FILING PARTY: PATENT OWNER
142
Order Denying Director Review of Final Written Decision MOTION
2026-07-22
FILING PARTY: BOARD
141
Patent Owner's Updated Mandatory Notices NOTICE
2026-07-20
FILING PARTY: PATENT OWNER
138
Petitioner's Fifth Motion to Seal MOTION
2026-07-17
FILING PARTY: PETITIONER
140
Authorized Review to Director Review Request NOTICE
2026-07-17
FILING PARTY: PETITIONER
3105
Email_Request for DR Denying PO's Motion to Terminate_Dismissed Exhibit
2026-07-15
FILING PARTY: BOARD
137
Patent Owner's Seventh Motion to Seal MOTION
2026-07-10
FILING PARTY: PATENT OWNER
3104
Ex. 3104 Email Correspondence Exhibit
2026-07-10
FILING PARTY: BOARD
135
Final Written Decision: original FINAL
2026-06-24
FILING PARTY: BOARD
134
Patent Owner's Request for Director Review of Order Denying Motion to Terminate (PUBLIC - REDACTED) OTHER
2026-06-23
FILING PARTY: PATENT OWNER
3103
Email, Subject_Merck v. Halozyme PGRs __ Filing of Request for Director Review Exhibit
2026-06-05
FILING PARTY: BOARD
1225
Deposition Transcript of Kelly Grez Exhibit
2026-06-03
FILING PARTY: PETITIONER
133
Patent Owner's Brief on Testimony of Ms. Kelly Grez (PUBLIC - UPDATED REDACTIONS) OTHER
2026-06-03
FILING PARTY: PATENT OWNER
129
Public Version of Oral Hearing Transcript OTHER
2026-05-26
FILING PARTY: PETITIONER
130
Public Order Denying Motion to Terminate OTHER
2026-05-26
FILING PARTY: PETITIONER
131
Patent Owner's Sixth Motion to Seal MOTION
2026-05-26
FILING PARTY: PATENT OWNER
128
ORDER Granting Petitioner’s Motion to Seal 37 C.F.R. §§ 42.14, 42.54 ORDER
2026-05-19
FILING PARTY: BOARD
126
Order: Granting PO's Motion to Seal ORDER
2026-05-19
FILING PARTY: BOARD
125
Order: Granting Renewed Motions to Seal ORDER
2026-05-18
FILING PARTY: BOARD
124
Patent Owner's Updated Mandatory Notices NOTICE
2026-05-13
FILING PARTY: PATENT OWNER
121
Other: Hearing transcript OTHER
2026-05-12
FILING PARTY: BOARD
113
Petitioner's Second Renewed Motion to Seal MOTION
2026-04-02
FILING PARTY: PETITIONER
114
Petitioner's Demonstratives OTHER
2026-04-02
FILING PARTY: PETITIONER
2501
EX2501 - Patent Owner's RPI Demonstratives (PUBLIC - REVISED REDACTIONS) Exhibit
2026-04-02
FILING PARTY: PATENT OWNER
115
Patent Owner's Renewed Fourth Motion to Seal MOTION
2026-04-02
FILING PARTY: PATENT OWNER
116
Petitioner's Fourth Motion to Seal MOTION
2026-04-02
FILING PARTY: PETITIONER
118
Petitioner's Supplemental Brief in Opposition to Patent Owner's Motion to Terminate OTHER
2026-04-02
FILING PARTY: PETITIONER
119
Patent Owner's Fifth Motion to Seal MOTION
2026-04-02
FILING PARTY: PATENT OWNER
112
Petitioner's Updated Exhibit List NOTICE
2026-03-27
FILING PARTY: PETITIONER
111
Order: ORDER Denying Without Prejudice Patent Owner’s and Petitioner’s Motions to Seal 37 C.F.R. §§ 42.14, 42.54 ORDER
2026-03-19
FILING PARTY: BOARD
110
Patent Owner's Notice of Grez Deposition NOTICE
2026-03-17
FILING PARTY: PATENT OWNER
109
Order: Granting Petitioner's Motion to Seal ORDER
2026-03-16
FILING PARTY: BOARD
1224
Declaration of Kelly Grez Exhibit
2026-03-12
FILING PARTY: PETITIONER
106
Petitioner's Third Motion to Seal MOTION
2026-03-12
FILING PARTY: PETITIONER
107
Petitioner's Updated Exhibit List NOTICE
2026-03-12
FILING PARTY: PETITIONER
104
Patent Owner's Motion to Terminate (PUBLIC - UPDATED REDACTIONS) OTHER
2026-03-11
FILING PARTY: PATENT OWNER
103
Order Conduct of the Proceedings ORDER
2026-03-03
FILING PARTY: BOARD
96
Order: Granting Petitioner's Motion to Seal ORDER
2026-02-27
FILING PARTY: BOARD
98
Patent Owner's Updated Exhibit List NOTICE
2026-02-27
FILING PARTY: PATENT OWNER
99
Patent Owner's Fourth Motion to Seal MOTION
2026-02-27
FILING PARTY: PATENT OWNER
2501
EX2501 - Patent Owner's RPI Demonstratives (PUBLIC - REDACTED) Exhibit
2026-02-27
FILING PARTY: PATENT OWNER
101
Petitioner's Demonstratives OTHER
2026-02-27
FILING PARTY: PETITIONER
100
Petitioner's Second Motion to Seal MOTION
2026-02-27
FILING PARTY: PETITIONER
102
ORDER Granting Patent Owner’s Motion to Seal 37 C.F.R. §§ 42.14, 42.54 ORDER
2026-02-27
FILING PARTY: BOARD
2500
EX2500 - Patent Owner's Demonstratives on the Merits Exhibit
2026-02-27
FILING PARTY: PATENT OWNER
93
Petitioner's Demonstratives Part 1 Slides 1-53 OTHER
2026-02-26
FILING PARTY: PETITIONER
92
Patent Owner's Reply in Support of Motion to Terminate (PUBLIC - REDACTED) OTHER
2026-02-26
FILING PARTY: PATENT OWNER
95
Petitioner's Demonstratives Part 3 Slides 106-153 OTHER
2026-02-26
FILING PARTY: PETITIONER
94
Petitioner's Demonstratives Part 2 Slides 54-105 OTHER
2026-02-26
FILING PARTY: PETITIONER
93
Patent Owner's Third Motion to Seal MOTION
2026-02-26
FILING PARTY: PATENT OWNER
90
Order: ORDER Conditionally Granting Patent Owner’s Motion to Seal 37 C.F.R. §§ 42.14, 42.54 ORDER
2026-02-25
FILING PARTY: BOARD
1241
Company Statement: “Merck Sues Merck KGaA, Darmstadt, Germany for Improper Use of “Merck”” (Jan. 15, 2016) Exhibit
2026-02-24
FILING PARTY: PETITIONER
86
Petitioner's Updated Exhibit List NOTICE
2026-02-24
FILING PARTY: PETITIONER
1243
Table Comparing the Boards of Directors for Merck & Co., Inc. and Merck Sharp & Dohme LLC Exhibit
2026-02-24
FILING PARTY: PETITIONER
1235
Merck & Co., Inc., Form 8-K (Nov. 4, 2009 Exhibit
2026-02-24
FILING PARTY: PETITIONER
1237
Merck & Co., Inc. Subsidiaries (Dec. 31, 2024 Exhibit
2026-02-24
FILING PARTY: PETITIONER
1239
Press Release: “Merck and Schering-Plough to Merge” (Mar. 9, 2009) Exhibit
2026-02-24
FILING PARTY: PETITIONER
1238
State of New Jersey, Certificate of Long Form Standing with Officers and Directors, Merck & Co., Inc. (Feb. 18, 2026) Exhibit
2026-02-24
FILING PARTY: PETITIONER
1240
State of New Jersey, Certificate of Long Form Standing with Officers and Directors, Merck Sharp & Dohme LLC (Feb. 18, 2026) Exhibit
2026-02-24
FILING PARTY: PETITIONER
1234
MSD Netherlands Capital B.V., Preliminary Prospectus Supplement (May 14, 2024) Exhibit
2026-02-24
FILING PARTY: PETITIONER
89
Petitioner's Opposition to Patent Owner's Motion to Terminate OPPOSITION
2026-02-24
FILING PARTY: PETITIONER
87
Petitioner's Motion to Seal MOTION
2026-02-24
FILING PARTY: PETITIONER
85
Patent Owner's Updated Exhibit List NOTICE
2026-02-20
FILING PARTY: PATENT OWNER
2401
EX2401 - E-mail (PUBLIC - REDACTED) Exhibit
2026-02-20
FILING PARTY: PATENT OWNER
2300
EX2300 - Naismith Declaration Errata Exhibit
2026-02-18
FILING PARTY: PATENT OWNER
84
Patent Owner's Sur-Reply OTHER
2026-02-18
FILING PARTY: PATENT OWNER
2301
EX2301 - Naismith Deposition Transcript Exhibit
2026-02-18
FILING PARTY: PATENT OWNER
2215
EX2215 - Khurana 2011 Exhibit
2026-02-18
FILING PARTY: PATENT OWNER
2302
EX2302 - Kelsoe Deposition Transcript Exhibit
2026-02-18
FILING PARTY: PATENT OWNER
83
ORDER Setting Oral Argument 37 C.F.R. § 42.70 ORDER
2026-02-17
FILING PARTY: BOARD
2458
EX2458 - Merck Co Bio Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2450
EX2450 - OED PTO Form 158 Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2454
EX2454 - Merck Co June 2025 Form 10-Q Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2451
EX2451 - Employment Letter Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2457
EX2457 - Sarbanes-Oxley Act 2002 Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2463
EX2463 - 2025 Merck Schedule 14A Proxy Statement Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2452
EX2452 - 2025-09-30 Merck Co SEC FORM 13F-HR Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2447
EX2447 - IPO Board of Directors Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2461
EX2461 - OED Search Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2462
EX2462 - 2024 MSD LLC Schedule 13D Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
79
Patent Owner's Updated Exhibit List NOTICE
2026-02-16
FILING PARTY: PATENT OWNER
2448
EX2448 - ChIPs - Speaker Details Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2446
EX2446 - Amicus Brief Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2449
EX2449 - LinkedIn Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2456
EX2456 - Merck 2024 Form 10K Exhibit 24.1 Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
80
Patent Owner's Second Motion to Seal MOTION
2026-02-16
FILING PARTY: PATENT OWNER
2460
EX2460 - MSD Bio Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2465
EX2465 - Merck OED Search Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
82
Patent Owner's Motion to Terminate (PUBLIC - REDACTED) OTHER
2026-02-16
FILING PARTY: PATENT OWNER
2468
EX2468 - Exhibit 99.2 to Form 8-K, Merck & Co. Inc., February 3, 2026 Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2466
EX2466 - Merck Form 8K Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2467
EX2467 - Merck Form 8K Exhibit 99.1 - Press Release Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2464
EX2464 - SEC Form 13F Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2459
EX2459 - NJ Rules of Professional Conduct Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
2453
EX2453 - 2025-09-30 MSD SEC FORM 13F-NT Exhibit
2026-02-16
FILING PARTY: PATENT OWNER
78
ORDER Conduct of the Proceedings 37 C.F.R. § 42.5 ORDER
2026-02-13
FILING PARTY: BOARD
3001
EX 3001 Exhibit
2026-02-13
FILING PARTY: BOARD
77
Order: Denying Patent Owners Motion for Additional Discovery 37 C.F.R. sec. 42.51 ORDER
2026-02-12
FILING PARTY: BOARD
74
Patent Owner's Updated Mandatory Notices NOTICE
2026-02-09
FILING PARTY: PATENT OWNER
75
Order: Conduct of Proceeding ORDER
2026-02-09
FILING PARTY: BOARD
3102
Ex. 3102 Attorney Correspondence Exhibit
2026-02-09
FILING PARTY: BOARD
76
Order: Granting Motion to Seal ORDER
2026-02-09
FILING PARTY: BOARD
73
Patent Owner's Notice of Naismith Deposition NOTICE
2026-01-30
FILING PARTY: PATENT OWNER
72
Patent Owner's Notice of Kelsoe Deposition NOTICE
2026-01-30
FILING PARTY: PATENT OWNER
3101
Ex. 3101 Email correspondence Exhibit
2026-01-29
FILING PARTY: BOARD
70
Patent Owner's Updated Power of Attorney NOTICE
2026-01-28
FILING PARTY: PATENT OWNER
69
Patent Owner's Notice of Intent to Designate Provisionally Recognized PTAB Practitioner as Back-up Counsel NOTICE
2026-01-28
FILING PARTY: PATENT OWNER
71
Petitioner's Reply to Patent Owner's Response REPLYTOOPP
2026-01-28
FILING PARTY: PETITIONER
2214
EX2214 - Summers Declaration Exhibit
2026-01-28
FILING PARTY: PATENT OWNER
68
Patent Owner's Objections to Evidence OTHER
2026-01-27
FILING PARTY: PATENT OWNER
1119
Csoka, A. et al., “The Six Hyaluronidase-Like Genes in the Human and Mouse Genomes” Matrix Biology 20:499-508 (2001) Exhibit
2026-01-23
FILING PARTY: PETITIONER
67
Petitioner's Updated Exhibit List NOTICE
2026-01-23
FILING PARTY: PETITIONER
1120
Huo, Z. et al., “Systemic and Mucosal Immune Responses to Sublingual or Intramuscular Human Papilloma Virus Antigens in Healthy Female Volunteers,” PLoS ONE 7(3):e33736 (2012) Exhibit
2026-01-23
FILING PARTY: PETITIONER
1125
Emails re: AutoDock Vina (Sept. 9, 2025 - Oct. 27, 2025) Exhibit
2026-01-23
FILING PARTY: PETITIONER
1122
Printz, M. et al., “Risk Factors, Hyaluronidase Expression, and Clinical Immunogenicity of Recombinant Human Hyaluronidase PH20, an Enzyme Enabling Subcutaneous Drug Administration,” AAPS 24(6):110 (2022) Exhibit
2026-01-23
FILING PARTY: PETITIONER
1126
Im, S. et al., “Cryo-EM Structure of Human Hyaluronidase PH- 20,” Proteins: Structure, Function, and Bioinformatics 93:1067- 1073 (2025) Exhibit
2026-01-23
FILING PARTY: PETITIONER
1150
Chowpongpang et al., “Cloning and characterization of the bovine testicular PH-20 hyaluronidase core domain” Biotechnol. Lett. 26(15):1247-52 (2004) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1172
Bolland, S., “An Innate Path to Human B Cell Tolerance,” Immunity, 29(5):667-9 (2008) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1179
Dormitzer, P. et al., “Influenza Vaccine Immunology,” Immunol Rev., 239(1):167-77 (2011) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1133
Declaration of James Naismith, Ph.D. Exhibit
2026-01-20
FILING PARTY: PETITIONER
1139
Chiti & Dobson, “Protein Misfolding, Functional Amyloid, and Human Disease” Annu. Rev. Biochem. 75:333–66 (2006) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1142
Farber & Petsko, “The evolution of alpha/beta barrel enzymes” Trends Biochem. Sci. 15(6):228-34 (1990) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1196
Dunn, C. et al., “Transcription of the Human and Rodent SPAM1 / PH-20 Genes Initiates Within an Ancient Endogenous Retrovirus,” BMC Genomics, 6:47 (2005) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1153
Petsko, “Herding CATS” Sci. Transl. Med. 24;3(97):97 (2011) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1174
Yewdell, J. et al., “Immunodominance in Major Histocompatibility Complex Class I-restricted T Lymphocyte Responses,” Annu. Rev. Immunol., 17:51–88 (1999) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1152
Ringe & Petsko, “Q&A: What are pharmacological chaperones and why are they interesting?” J. Biol. 8:80 (2009) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1148
Reed et al., “Use of Coefficient of Variation in Assessing Variability of Quantitative Assays” Clin. Diagn. Lab Immunol. 9(6):1235-9 (2002) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1140
Dobson, “Protein misfolding, evolution and Disease” Trends Biochem. Sci. (9):329-32 (1999) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1201
Rodriguez, L. et al., “Foot and mouth disease virus vaccines,” Vaccine 27:D90-D94 (2009) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1195
Zhang, H. et al., “Mouse Spam1 (PH-20) Is a Multifunctional Protein: Evidence for Its Expression in the Female Reproductive Tract,” Biol Reprod., 69(2):446-54 (2003) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1188
Cherr, G. et al., “The Dual Functions of GPI-Anchored PH-20: Hyaluronidase and Intracellular Signaling,” Matrix Biol., 20(8):515-25 (2001) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1191
McCutcheon, J. et al., “HLA-B*0702 Antibody Epitopes are Affected Indirectly by Distant Antigen Residues,” Hum Immunol., 36(2):69-75 (1993) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1162
Koch, C. et al., “A Comparison of the Immunogenicity of the Native and Denatured Forms of a Protein,” APMIS 104:115-125 (1996) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1137
Dobson, “Protein folding and misfolding” Nature. 18;426(6968):884-90 (2003) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1170
Murphy, K., “Janeway’s Immuno Biology,” (8th 2012), Chapters 1, 4, 8, 10, 11, 12, 15, and Appx I (Part 1) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1175
Popova, L. et al., “Immunodominance of Antigenic Site B over Site A of Hemagglutinin of Recent H3N2 Influenza Viruses,” PLoS One, 7(7):e41895 (2012) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1197
Hirsch, C. et al., “The Ubiquitylation Machinery of the Endoplasmic Reticulum,” Nature, 458(7237):453-60 (2009) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1170
Murphy, K., “Janeway’s Immuno Biology,” (8th 2012), Chapters 1, 4, 8, 10, 11, 12, 15, and Appx I (Part 2) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1160
Poelwijk, Frank J., et al., “Empirical fitness landscapes reveal accessible evolutionary paths” Nature 445.7126 (2007): 383-386 Exhibit
2026-01-20
FILING PARTY: PETITIONER
1169
Declaration of Jeffrey P. Kushan (Petitioner's Reply) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1187
Montefiori, D. et al., “Magnitude and Breadth of the Neutralizing Antibody Response in the RV144 and Vax003 HIV-1 Vaccine Efficacy Trials,” Journal of Infectious Disease, 206(3):431-41 (2012) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1189
Martin-Deleon, “Epididymal SPAM1 and its Impact on Sperm Function” Molecular and Cellular Endocrinology 250:114-121 (2006) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1178
Nelson, C. et al., “Peptides Determine the Lifespan of MHC Class II Molecules in the Antigen-Presenting Cell,” Nature, 371(6494):250-2 (1994) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1180
Mantis, NJ., et al., “Secretory IgA ’ s Complex Roles in Immunity and Mucosal Homeostasis in the Gut,” Mucosal Immunol., 4(6):603-11 (2011) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1184
Laver, W. et al., “Epitopes on Protein Antigens: Misconceptions and Realities,” Cell 61:553-556 (1990) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1192
Nobusawa, E. et al., “Comparison of Complete Amino Acid Sequences and Receptor-Binding Properties among 13 Serotypes of Hemagglutinins of Influenza A Viruses,” Virology, 182(2):475-85 (1991) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1149
Ten Have et al., “Cloning and characterization of the cDNA encoding the PH20 protein in the European red fox Vulpes vulpes” Reprod. Fertil. Dev. 10(2):165-72 (1998) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1199
Li, M. et al., “Importance of Glycosylation and Disulfide Bonds in Hyaluronidase Activity of Macaque Sperm Surface PH-20,” J Androl., 23(2):211-9 (2002) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1157
Chiti et al., “Rationalization of the effects of mutations on peptide and protein aggregation rates” Nature, 424:805-808 (2003) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1177
Rolland, M. et al., “Recognition of HIV-1 Peptides by Host CTL Is Related to HIV-1 Similarity to Human Proteins,” PLoS One, 2(9):e823 (2007) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1155
Calloni et al., “Investigating the Effects of Mutations on Protein Aggregation in the Cell” J. Biol. Chem. 10607-13 (2005) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1154
Second Table Associating Citations from the ’035 Patent (EX1001) to Corresponding Citations in the ’731 Application (EX1026) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1181
Siskin, G. and Eisen, H., “Effect of Variation in Antibody-Hapten Association Constant upon the Biologic Activity of the Antibody,” J Immunol., 95(3):436-41 (1965) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1147
Van Rossum et al., “Reporter-based screening and selection of enzymes” FEBS J. 280:2979-96 (2013) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1183
Fauci, A. et al., “The Relationship between Antibody Affinity and the Efficiency of Complement Fixation,” J Immunol., 105(1):215- 20 (1970) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1134
Declaration of Dr. Garnett Kelsoe Exhibit
2026-01-20
FILING PARTY: PETITIONER
1027
2024 Chemistry Nobel Prize Background Exhibit
2026-01-20
FILING PARTY: PETITIONER
1204
Nikolova E. et al., “All Forms of Human IgA Antibodies Bound to Antigen Interfere with Complement (C3) Fixation Induced by IgG or by Antigen Alone,” Scand J Immunol., 39(3):275-80 (1994) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1144
Ochoa-Levya et al., “Protein Design through Systematic Catalytic Loop Exchange in the (beta/alpha)8 Fold” J. Mol. Biol. 10 387(4):949-64 (2009) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1132
Transcript of the Deposition of Dr. James Moon, Ph.D., November 18, 2025 Exhibit
2026-01-20
FILING PARTY: PETITIONER
1159
Brachmann et al., “Genetic selection of intragenic suppressor mutations that reverse the effect of common p53 cancer mutations” EMBO Journal 17:1847–59 (1998) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1143
Nagano et al., “One Fold with Many Functions: The Evolutionary Relationships between TIM Barrel Families Based on their Sequences, Structures and Functions” J. Mol. Biol. 30;321(5):741-65 (2002) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1141
Goldsmith & Tawfik, “Directed enzyme evolution: beyond the low-hanging fruit” Curr. Opin. Struct. Biol. 22(4):406-12 (2012) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1136
Dobson, “Principles of protein folding, misfolding and aggregation” Semin. Cell. Dev. Biol. 15(1):3-16 (2004) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1203
Russell, M. et al., “Complement-Fixing Properties of Human IgA Antibodies. Alternative Pathway Complement Activation by Plastic-Bound, but not Specific Antigen-Bound, IgA,” Scand J Immunol., 30(2):175-83 (1989) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1198
Singh, S., et al., “Solubilization and Refolding of Bacterial Inclusion Body Proteins,” Journal of Bioscience and Bioengineering 99:303-310 (2005) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1163
Leder, L. et al., “Genuine and Apparent Cross-Reaction of Polyclonal Antibodies to Proteins and Peptides,” Eur. J. Biochem. 219:73-81 (1994) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1186
Kemp, T. et al., “Evaluation of Systemic and Mucosal Anti-HPV16 and Anti-HPV18 Antibody Responses from Vaccinated Women,” Vaccine, 26(29-30):3608-16 (2008) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1158
Wang et al., “Immunogenicity of protein aggregates-Concerns and Realities” Int. J. Pharmaceutics 431:1-11, (2012) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1135
Dr. Naismith Analysis Spreadsheet Exhibit
2026-01-20
FILING PARTY: PETITIONER
1145
AutoDock Vina Tutorial 2011 Exhibit
2026-01-20
FILING PARTY: PETITIONER
1173
Anderson, M. et al., “Projection of an Immunological Self Shadow Within the Thymus by the Aire Protein,” Science, 298(5597):1395- 401 (2002) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1146
Pal et al., “Comprehensive and Quantitative Mapping of Energy Landscapes for Protein-Protein Interactions by Rapid Combinatorial Scanning” J. Biol. Chem. 4;281(31):22378-22385 (2006) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1130
Melanie Ann Simpson, Ph.D. Deposition Transcript Exhibit
2026-01-20
FILING PARTY: PETITIONER
1171
Yang, X. et al., “An Introduction to Epitope Prediction Methods and Software,” Rev. Med. Virol., 19: 77–96 (2009) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1151
Fowler et al., “High-resolution mapping of protein sequencefunction relationships” Nature Methods 7, 741–746 (2010) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1138
Dobson, “Experimental investigation of protein folding and misfolding” Methods 34(1):4-14 (2004) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1161
Primakoff, P. et al., “Purification of the guinea pig sperm PH-20 antigen and detection of a site-specific endoproteolytic activity in sperm preparations that cleaves PH-20 into two disulfide-linked fragments,” Biology of Reproduction 38:921-934 (1988) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1190
Nolan et al., “The Safety of Recombinant Human Hyaluronidase PH20 in Nonclinical Models: An Overview of Toxicology, Pharmacology, and Impact of Anti-PH20 Antibodies,” Journal of Controlled Release, 374:369-383 (2024) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1185
Lu, X. et al., “Anti-gp160 IgG and IgA Antibodies Associated with a Large Increase in Total IgG in Cervicovaginal Secretions from Human Immunodeficiency Virus Type l-Infected Women,” Journal of Infectious Disease, 167(5):1189-92 (1993) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1205
Goodey, N. et al., “Allosteric Regulation and Catalysis Emerge via a Common Route,” Nat Chem Biol. 4(8):474-82 (2008) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1131
Gregory Petsko, Ph.D. Deposition Transcript Exhibit
2026-01-20
FILING PARTY: PETITIONER
1156
Chiti et al., “Studies of aggregation of mutant proteins in vitro provided insights into genetics of amyloid diseases” PNAS 99:16419-26 (2002) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1176
Gershoni, J. et al., “Epitope Mapping: The First Step in Developing Epitope-Based Vaccines,” BioDrugs, 21(3):145-56 (2007) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1129
Transcript of the Deposition of Dr. Gary Cherr, Ph.D., November 12, 2025 Exhibit
2026-01-20
FILING PARTY: PETITIONER
1202
Redwood, A. et al., “Viral Vectored Immunocontraception: Screening of Multiple Fertility Antigens using Murine Cytomegalovirus as a Vaccine Vector,” Vaccine, 25(4):698-708 (2007) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1182
Levine, B. and Levytska, V., “A Sensitive Hemagglutination Assay Method for Dinitrophenyl-Specific Antibodies. The Effect of Antibody Binding Affinity on Titers,” J Immunol., 98(3):648-52 (1967) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1193
CDC on H5N1 CDC Press Release: “Highly Pathogenic Avian Influenza A (H5N1) Virus Infection Reported in a Person in the U.S.” (Apr. 1, 2024) Exhibit
2026-01-20
FILING PARTY: PETITIONER
1165
MERCK_PGR00458 - PTAB-PGR2021-00036-16 Merck- Genentech PGR Exhibit
2026-01-19
FILING PARTY: PETITIONER
1167
MERCK_PGR00094 - DNJ-2-25-cv-03179 Stipulation to Substitute Parties Exhibit
2026-01-19
FILING PARTY: PETITIONER
65
Petitioner's Request for Oral Argument OTHER
2026-01-19
FILING PARTY: PETITIONER
64
Patent Owner's Request for Oral Argument OTHER
2026-01-19
FILING PARTY: PATENT OWNER
1164
MERCK_PGR00355 - PTAB-PGR2021-00036-1 Merck- Genentech PGR Exhibit
2026-01-19
FILING PARTY: PETITIONER
1166
MERCK_PGR00462 - RE_ 2_25-cv-03179-ES-JRA_ HALOZYME, INC. v. MERCK SHARP & DOHME CORP. Exhibit
2026-01-19
FILING PARTY: PETITIONER
63
Petitioner's Opposition to Patent Owner's Motion for Additional Discovery OPPOSITION
2026-01-19
FILING PARTY: PETITIONER
1168
MERCK_PGR00090 - DNJ-2-25-cv-03179 2025-07-14 [019] Corporate Disclosure Statement Exhibit
2026-01-19
FILING PARTY: PETITIONER
2421
EX2421 - IPR2024-00625 Petition Exhibit
2026-01-06
FILING PARTY: PATENT OWNER
2409
EX2409 - Board of Directors - MSD Exhibit
2026-01-06
FILING PARTY: PATENT OWNER
2416
EX2416 - USPTO OED Practitioner Search - Mark Stewart registration Exhibit
2026-01-06
FILING PARTY: PATENT OWNER
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